EXCHANGE
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- Siponimod
Sphingosine 1-phosphate receptor Edg-1 agonist
Results by group
Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE) Related to Study Drug During the Treatment Period
From first dose of study drug up to 30 days after last dose of study drug (up to 7 months)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Siponimod | 59 Participants | 185 |
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Siponimod | 185 | 9 (4.9%) | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE) Related to Study Drug During the Treatment Period
From first dose of study drug up to 30 days after last dose of study drug (up to 7 months)
Safety
Other measures (5)
Number of Participants With at Least One Adverse Event (AE)
From first dose of study drug up to 30 days after last dose of study drug (up to 7 months)
SafetyChange From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM-9)
Baseline up to Day 168
Quality of life (reported by participants)Change in Heart Rate From Baseline to 6 Hours After First Treatment
From the first dose up to 6 hours
Number of Participants With at Least One Hospitalization During the Treatment
From first dose of study drug up to last dose of study drug (up to 6 months)
Patient Retention Reported as Number of Participants Who Completed the Study
From first dose of study drug up to 30 days after last dose of study drug (up to 7 months)
Feasibility
Who could take part
Relapsing MS · 18 to 65
Key Inclusion Criteria: 1. Signed informed consent. 2. Male or female aged 18 to 65 years (inclusive). 3. Patients with advancing RMS as defined by the principal investigator. 4. Prior history of relapsing MS (RMS), with or without progressive features, according to the 2010 Revised McDonald or Lublin criteria (Lublin et al, 2013). 5. EDSS score of >/= 2.0 to 6.5 (inclusive). 6. Having been continuously treated with RMS Disease Modifying Therapies. Key Exclusion criteria: 1. Pregnant or nursing (lactating) women. 2. Patients with any medically unstable condition as determined by the investigator. 3. Certain cardiac risk factors defined in the protocol 4. History of hypersensitivity to the study drug or to drugs of similar chemical classes. Other protocol-defined inclusion/exclusion criteria may apply.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
To assess safety and tolerability of patients converting from approved Relapsing Multiple Sclerosis (RMS) Disease Modifying Therapies (DMTs) to siponimod.
Papers
Loading reviews and guidelines…
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History
Started
Feb 2019
Main results due
Jul 2022
Finished
Jul 2022
Results posted
Jul 2023
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